CompletedPhase 4

Duloxetine As an Analgesic in Patients Without Central Sensitivity After Same Sitting Bilateral Total Knee Arthroplasty

India106 participantsStarted 2021-01-01

Plain-language summary

Analgesic effect of 20mg Duloxetine was evaluated at regular short term intervals in patients without central sensitivity and undergoing bilateral single sitting total knee arthroplasty for tricompartmental osteoarthritis using standardised patient related outcome measures like the visual analogue score.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Bilateral tricompartmental knee osteoarthritis * Underwent primary, bilateral TKA in single-sitting Exclusion Criteria: * American Society of Anesthesiologists physical status IV * Hamilton Depression Scale (HAMD) and/or Hamilton Anxiety Scale (HAMA) scores \> 7 * known intolerance or allergy to any of the study drugs, alcohol, tobacco, narcotic, or opioid dependence * patients on anticoagulants * known hepatic/renal dysfunction * serious cardiac/cerebrovascular comorbidities * HbA1c≥7 * patients who were already on duloxetine or other SNRIs, monoamine oxidase inhibitors, tricyclic antidepressants, triptans, lithium, other antiepileptics, or buspirone.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

resting Visual Analogue Score for pain

Timeframe: from enrolment to 3 months after surgery

Visual Analogue Score for pain on movement

Timeframe: from enrolment to 3 months after surgery

Trial details

NCT IDNCT06837012

SponsorOrthopaedic Arthroscopy Knee and Shoulder Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-07-31

View on ClinicalTrials.gov More Osteoarthritis of Knee trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.